Condition category
Nutritional, Metabolic, Endocrine
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
30/09/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Niall Furlong

ORCID ID

Contact details

Research Fellow
Diabetes Centre
Whiston Hospital
Prescot
Merseyside
L35 5DR
United Kingdom
+44 (0)151 426 1600

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0237101842

Study information

Scientific title

Acronym

Study hypothesis

The aim of the present open-labelled, randomised controlled study is to examine effectiveness of insulin glargine in combination with metformin 1 g twice daily (bid) - 1 g three times a day (tds) compared with insulatard combined with metformin (same dose) in type two diabetic patients currently treated with insulatard/metformin combination therapy.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Diabetes

Intervention

Randomised controlled trial. Patients randomised to:
1. Nocturnal insulin glargine
2. Human insulatard in combination with metformin

Intervention type

Drug

Phase

Not Specified

Drug names

Glargine, metformin, insulatard

Primary outcome measures

1. Glycosylated haemoglobin (HbA1c)
2. Tasting blood glucose
3. Frequency of hypoglycaemia
4. Weight change

Secondary outcome measures

Well being and diabetes treatment satisfaction measured using appropriate validated questionnaires.

Overall trial start date

01/08/2001

Overall trial end date

31/07/2003

Reason abandoned

Eligibility

Participant inclusion criteria

80 patients.

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

80

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/08/2001

Recruitment end date

31/07/2003

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Research Fellow
Prescot, Merseyside
L35 5DR
United Kingdom

Sponsor information

Organisation

Department of Health (UK)

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

http://www.doh.gov.uk

Funders

Funder type

Government

Funder name

St Helens and Knowsley Hospitals NHS Trust (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes